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. 2009 Jan;11(1):21–34. doi: 10.1097/GIM.0b013e31818efd77

Table 1.

Key questions relating to the analytic framework

  1. Does testing for UGT1A1 mutations in patients with metastatic CRC treated with irinotecan lead to improvement in outcomes (e.g., irinotecan toxicity, response to treatment, morbidity and mortality) compared with no testing? (Overarching question)

  2. What is the analytic validity of the test(s) that identify key UGT1A1 mutations?

  3. What is the clinical validity of UGT1A1 testing?

    1. How well does UGT1A1 testing predict phenotypic markers (e.g., increased plasma SN-38 levels or decreased enzyme activity) and associated adverse drug reactions (e.g., diarrhea or neutropenia)?

    2. How well does UGT1A1 testing in patients with metastatic CRC predict morbidity and mortality?

    3. Do other factors (e.g., race/ethnicity, other medications) independently affect clinical validity?

  4. What are the benefits and harms (clinical utility) related to UGT1A1 testing for patients with metastatic CRC treated with irinotecan?

    1. Based on UGT1A1 test results, what are the management options for patients?

    2. Do these options improve patient outcomes or management decisions by patients or providers?